1.Pre-operative risk assessment of hepatocellular carcinoma recurrence in liver transplant recipients by non-invasive detection of pre-existing genetic lesions
Suqin YANG ; Sunbin LING ; Jianhua LI ; Yan WANG ; Jiapei WANG ; Qiwei HUANG ; Fanming LIU ; Yiqi ZHUANG ; Yingyu ZHENG ; Rui WANG ; Zhe YANG ; Xiaoping ZHENG ; Kai WANG ; Zhikun LIU ; Jun CHEN ; Jianguo WANG ; Haiyang XIE ; Lin ZHOU ; Leiming CHEN ; Guoqiang CAO ; Dandan CHEN ; Junfang JI ; Bin ZHAO ; Chao JIANG ; Di LU ; Xuyong WEI ; Hangjin JIANG ; Qiaonan SHAN ; Hengbo SHI ; Yong-Zhen XU ; Shusen ZHENG ; Zhengxin WANG ; Shengda LIN ; Xiao XU
Clinical and Molecular Hepatology 2026;32(2):884-903
Background/Aims:
Liver transplantation (LT) following total hepatectomy is a life-saving treatment for hepatocellular carcinoma (HCC). The HCC recurrence after LT hinders the effectiveness of the procedure. The objective of this study is to develop a pre-operative risk stratification model based on a liquid biopsy.
Methods:
We conducted a comprehensive multi-omics study of 260 HCC patients from three centers, including clinical data, low-coverage whole-genome sequencing of cell-free DNA (cfDNA) from plasma, as well as whole-exome, single-nucleus RNA, and spatial transcriptomics from matched tumor and non-tumor tissues.
Results:
We identified cfDNA-derived copy number alteration (CNA) signatures associated with post-transplant recurrence. By integrating cfDNA-derived CNA profiles with single-cell transcriptomic data, we traced recurrence-associated cfDNA to a distinct subpopulation of malignant cells within the primary tumor. These cells were embedded in a pro-metastatic microenvironment of specialized endothelial subtypes and cancer-associated fibroblasts. Notably, most recurrence-associated lesions were detectable in cfDNA prior to liver transplantation (LT). Building on these insights, we developed the ZJU Criteria based on CNA fragments and tumor markers, a pre-LT risk prediction tool that integrates conventional clinical factors with cfDNA-derived CNA signatures, and validated it using internal and independent external cohorts.
Conclusion
Our findings suggest that post-transplant recurrence commonly originates from advanced subclones that emerge late during tumor evolution. The ZJU Criteria provides an accurate, non-invasive strategy that significantly improves pre-LT risk stratification and clinical decision-making for patients with HCC.
2.Clinical value of low molecular weight heparin bridging therapy for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents
Wei YANG ; Jinlin LIU ; Kai LIN ; Yong PAN ; Fan LUO ; Gaopin ZHAO ; Chun YANG
Chinese Journal of Digestive Surgery 2025;24(9):1180-1185
Objective:To investigate the clinical value of low molecular weight heparin bridging therapy for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents.Methods:The propensity score matching and retrospective cohort study was conducted. The clinical data of 126 patients undergoing tension-free inguinal hernia repair who with long-term oral antiplatelet agents and admitted to Sichuan Academy of Medical Sciences & Sichuan Provincial People′s Hospital (Affiliated Hospital of University of Electronic Science and Technology of China) from January 2017 to January 2025 were collected. There were 120 males and 6 females, aged (74±9)years. Of the 126 patients, 77 patients who discontinued antiplatelet agents alone before inguinal hernia repair were set as the drug withdrawal group, and 49 patients who discontinued antiplatelet agents with low molecular weight heparin bridging therapy before inguinal hernia repair were set as the bridging group. Observation indicators: (1) propensity score matching and comparison of general data of patients between the two groups after matching; (2) intraoperative and postopera-tive conditions; (3) follow-up. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test or Fisher exact probability. Propensity score matching was performed using the 1∶1 nearest neighbor matching method. The caliper value was set as 0.1. Results:(1) Propensity score matching and comparison of general data of patients between the two groups after matching. Of the 126 patients, 90 patients were success-fully matched, with 45 cases in each of the drug withdrawal group and the bridging group. After propensity score matching, the elimination of hernia ring size, activated partial thromboplasmin time and surgical method factors confounding bias ensured comparability. (2) Intraoperative and postoperative conditions. After propensity score matching, patients using plasma drainage tubes during the operation in the drug withdrawal group and the bridging group were 8 and 1, respec-tively, showing a significant difference between the two groups ( P<0.05). The visual analogue scale scores of patients in the drug withdrawal group and the bridging group at 48 hours after surgery were 2(range, 1-2) and 2(range, 2-3), respectively, showing a significant difference between the two groups ( Z=-2.57, P<0.05). (3) Follow-up. After propensity score matching, all 90 patients were followed up after surgery for 16.5(range, 9.0-30.0)days. During the follow-up period, there was no significant difference in pain, seroma, incisional infection, readmission within 30 days after surgery getween two groups (P>0.05). No serious thrombotic events occurred in either group of patients, and no patient died. Conclusion:Compared with patients who discontinued antiplatelet agents alone before surgery, preoperative low molecular weight heparin bridging therapy after discontinua-tion of medication is safe and feasible for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents, in additon to less plasma drainage tubes using during the operation and without more risk of bleeding, but more postoperative pain.
3.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
4.Selective hemivertebrae resection for lumbosacral combined with thoracolumbar/lumbar hemimetameric segmental shift deformities: efficacy and complications
Jie ZHOU ; Song LI ; Kai SUN ; Zhen LIU ; Yong QIU ; Zezhang ZHU ; Saihu MAO
Chinese Journal of Orthopaedics 2025;45(9):542-551
Objective:To explore a selective resection strategy for combined lumbosacral hemivertebra (LSHV) and thoracolumbar hemivertebra/lumbar hemivertebra (TLHV/LHV) double-balanced hemivertebra deformities.Methods:A retrospective analysis was conducted on 21 patients aged over 10 years with lumbosacral and thoracolumbar or lumbar combined hemimetameric segmental shift (HMMS) deformities who underwent surgery at Nanjing Drum Tower Hospital between May 2009 and October 2022. The cohort included 7 males and 14 females, with a mean surgical age of 21.5±10.9 years (range: 12-55 years) and a mean follow-up duration of 32.8±15.9 months (range: 24-74 months). Patients were divided into two groups based on preoperative coronal balance: the balanced group (Type A) and the unbalanced group (Type C). Radiographic parameters, including the major Cobb angle, lumbosacral take-off angle, kyphotic angle, coronal balance distance (CBD), and the deviation of the upper instrumented vertebra (UIV), were measured preoperatively, postoperatively, and at the final follow-up. Surgical complications were also recorded.Results:Of the 21 patients, 11 were classified as preoperatively balanced, and 10 as unbalanced. The deformity angular ratio of thoracolumbar to lumbosacral curves was significantly higher in the balanced group than in the unbalanced group (0.9±0.3 vs. 0.6±0.2; t=2.143, P=0.045). The preoperative main curve Cobb angles in the balanced and imbalanced groups were 71.3°±22.3° and 58.6°±8.2°, respectively. One week postoperatively, these angles were reduced to 38.4°±17.6° and 31.3°±5.6°, and were maintained at 40.0°±18.1° and 32.6°±5.6° at the final follow-up, all differences were statistically significant ( P<0.05). The preoperative lumbosacral take-off angles were 37.5°±9.1° in the balanced group and 36.7°±7.7° in the imbalanced group, which decreased to 18.4°±9.4° and 19.2°±5.5° at 1 week postoperatively, and remained at 19.4°±10.1° and 19.6°±5.8° at the final follow-up. These changes were also statistically significant ( P<0.05). In the balanced group, the UIV tilt angle, the CBD and the deviation of the UIV, were all significantly reduced compared to preoperative values ( P<0.05). Among the 21 patients, LSHV resection was performed in 15 cases, and TLHV/LHV resection was performed in 7 cases. Among the 15 patients with kyphosis, TLHV/LHV resection was performed in 6 cases. In the balanced group, 9 patients maintained type A postoperatively, including 4 patients with LSHV resection, 2 with TLHV/LHV resection, 2 with both LSHV and TLHV/LHV resection, 1 without resection of both hemivertebra. Two patients in the balanced group who underwent TLHV/LHV resection experienced postoperative deterioration to type C. In the unbalanced group, 8 cases with LSHV resection improved to type A, while 1 case with LSHV resection and 1 case with neither resection maintained C-type. In the LSHV resection group, CBD improved from 29.8±15.2 mm to 13.9±5.7 mm postoperatively and remained stable at 14.6±8.6 mm at final follow-up. Only 1 patient in this group experienced worsened coronal imbalance. In contrast, in the non-LSHV resection group, CBD worsened from 17.2 ± 8.7 mm to 19.7±12.1 mm postoperatively, progressing further to 20.5±13.0 mm at follow-up. Three patients in this group had worsening coronal imbalance, and 2 required revision surgery. Reported complications included 3 cases of internal fixation fracture, 1 case of proximal junctional kyphosis, and 1 case of acute incision infection. Conclusions:Effective resection of lumbosacral hemivertebrae is the preferred selective strategy, particularly for patients with preoperative coronal imbalance, as it significantly reduces the risk of worsening coronal imbalance and internal fixation-related complications. However, selective resection involving only TLHV or LHV without addressing LSHV in preoperatively balanced patients may increase the risk of postoperative coronal imbalance.
5.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
6.Selective hemivertebrae resection for lumbosacral combined with thoracolumbar/lumbar hemimetameric segmental shift deformities: efficacy and complications
Jie ZHOU ; Song LI ; Kai SUN ; Zhen LIU ; Yong QIU ; Zezhang ZHU ; Saihu MAO
Chinese Journal of Orthopaedics 2025;45(9):542-551
Objective:To explore a selective resection strategy for combined lumbosacral hemivertebra (LSHV) and thoracolumbar hemivertebra/lumbar hemivertebra (TLHV/LHV) double-balanced hemivertebra deformities.Methods:A retrospective analysis was conducted on 21 patients aged over 10 years with lumbosacral and thoracolumbar or lumbar combined hemimetameric segmental shift (HMMS) deformities who underwent surgery at Nanjing Drum Tower Hospital between May 2009 and October 2022. The cohort included 7 males and 14 females, with a mean surgical age of 21.5±10.9 years (range: 12-55 years) and a mean follow-up duration of 32.8±15.9 months (range: 24-74 months). Patients were divided into two groups based on preoperative coronal balance: the balanced group (Type A) and the unbalanced group (Type C). Radiographic parameters, including the major Cobb angle, lumbosacral take-off angle, kyphotic angle, coronal balance distance (CBD), and the deviation of the upper instrumented vertebra (UIV), were measured preoperatively, postoperatively, and at the final follow-up. Surgical complications were also recorded.Results:Of the 21 patients, 11 were classified as preoperatively balanced, and 10 as unbalanced. The deformity angular ratio of thoracolumbar to lumbosacral curves was significantly higher in the balanced group than in the unbalanced group (0.9±0.3 vs. 0.6±0.2; t=2.143, P=0.045). The preoperative main curve Cobb angles in the balanced and imbalanced groups were 71.3°±22.3° and 58.6°±8.2°, respectively. One week postoperatively, these angles were reduced to 38.4°±17.6° and 31.3°±5.6°, and were maintained at 40.0°±18.1° and 32.6°±5.6° at the final follow-up, all differences were statistically significant ( P<0.05). The preoperative lumbosacral take-off angles were 37.5°±9.1° in the balanced group and 36.7°±7.7° in the imbalanced group, which decreased to 18.4°±9.4° and 19.2°±5.5° at 1 week postoperatively, and remained at 19.4°±10.1° and 19.6°±5.8° at the final follow-up. These changes were also statistically significant ( P<0.05). In the balanced group, the UIV tilt angle, the CBD and the deviation of the UIV, were all significantly reduced compared to preoperative values ( P<0.05). Among the 21 patients, LSHV resection was performed in 15 cases, and TLHV/LHV resection was performed in 7 cases. Among the 15 patients with kyphosis, TLHV/LHV resection was performed in 6 cases. In the balanced group, 9 patients maintained type A postoperatively, including 4 patients with LSHV resection, 2 with TLHV/LHV resection, 2 with both LSHV and TLHV/LHV resection, 1 without resection of both hemivertebra. Two patients in the balanced group who underwent TLHV/LHV resection experienced postoperative deterioration to type C. In the unbalanced group, 8 cases with LSHV resection improved to type A, while 1 case with LSHV resection and 1 case with neither resection maintained C-type. In the LSHV resection group, CBD improved from 29.8±15.2 mm to 13.9±5.7 mm postoperatively and remained stable at 14.6±8.6 mm at final follow-up. Only 1 patient in this group experienced worsened coronal imbalance. In contrast, in the non-LSHV resection group, CBD worsened from 17.2 ± 8.7 mm to 19.7±12.1 mm postoperatively, progressing further to 20.5±13.0 mm at follow-up. Three patients in this group had worsening coronal imbalance, and 2 required revision surgery. Reported complications included 3 cases of internal fixation fracture, 1 case of proximal junctional kyphosis, and 1 case of acute incision infection. Conclusions:Effective resection of lumbosacral hemivertebrae is the preferred selective strategy, particularly for patients with preoperative coronal imbalance, as it significantly reduces the risk of worsening coronal imbalance and internal fixation-related complications. However, selective resection involving only TLHV or LHV without addressing LSHV in preoperatively balanced patients may increase the risk of postoperative coronal imbalance.
7.Construction of a postoperative mortality risk model for patients with acute aortic dissection based on XGBoost-SHAP method
Xin ZHANG ; Min FANG ; Yi CAO ; Ting-Ting LI ; Xian-Kong LIU ; Jia-Yi DANG ; Xue-Sen ZHAO ; Hong-Qin REN ; Jia-Ze GENG ; Kai-Wen WANG ; Tie-Sheng HAN ; Yong-Bo ZHAO ; Dong MA
Medical Journal of Chinese People's Liberation Army 2025;50(10):1226-1234
Objective To develop a predictive model for postoperative mortality risk in patients with acute aortic dissection(AAD)using the Extreme Gradient Boosting(XGBoost)algorithm combined with Shapley Additive Explanation(SHAP),and to establish a prediction website to serve as a diagnostic and therapeutic support platform for clinicians and patients.Methods A retrospective cohort study design was adopted.Data from 782 AAD patients who underwent surgical treatment at the Fourth Hospital of Hebei Medical University from January 2013 to December 2023 were collected,including basic information and initial serum biomarker test results.Patients were randomly divided into training and test sets at a 7:3 ratio.An external validation set consisting of 313 AAD patients admitted to the Second Hospital of Hebei Medical University from January 2020 to December 2023 was also established for further model validation.Variables were screened using LASSO regression,and an XGBoost machine learning model was constructed and interpreted using SHAP.The predictive performance of the model was evaluated using receiver operating characteristic(ROC)curve analysis.Using the Shiny package,the XGBoost model was deployed to shinyapps.io to create a prediction website for postoperative mortality risk in AAD patients.One patient was selected by simple random sampling from the test set and the external validation set respectively for the prediction example on the Shiny webpage.Results The XGBoost model demonstrated high predictive performance for postoperative mortality in AAD patients,with area under the ROC curve(AUC)values of 0.928(95%CI 0.901-0.956)in the training set,0.919(95%CI 0.891-0.949)in the test set,and 0.941(95%CI 0.915-0.967)in the external validation set.SHAP values indicated the following order of variable importance in the model(from highest to lowest):"lactate dehydrogenase""blood chlorine""multiple organ injury""carbon dioxide combining power""prothrombin time""α-hydroxybutyric acid""creatine kinase isoenzyme""Stanford classification""combined use of bedside blood purification""gender""acute kidney injury""gastrointestinal bleeding""brain injury"and"shock".A risk prediction website for adverse postoperative outcomes in AAD patients was developed using XGBoost-SHAP method(https://dun-dunxiaolu.shinyapps.io/document/)and validated with examples.One randomly selected patient from each of the test and external validation sets was applied:the predicted mortality risk value for patient 1(who died postoperatively)was 0.9539,and that for patient 2(who survived postoperatively)was 0.0206.Conclusions The XGBoost-SHAP model demonstrates high accuracy in predicting postoperative mortality risk for AAD patients.The online prediction tool established based on this model enhances the identification efficiency of high-risk postoperative mortality patients.
8.Asian consensus on normothermic intraperitoneal and systemic treatment for gastric cancer with peritoneal metastasis
Zhenggang ZHU ; Kitayama Joji ; Hyung-Ho Kim ; Jimmy Bok-Yan So ; Hui CAO ; Lin CHEN ; Xiangdong CHENG ; Jiankun HU ; Imano Motohiro ; Ishigami Hironori ; Ye Seob Jee ; Jong-Han Kim ; Yasuhiro Kodera ; Han LIANG ; Xiaowen LIU ; Sheng LU ; Yiping MOU ; Mingming NIE ; Won Jun Seo ; Yanong WANG ; Dan WU ; Zekuan XU ; Yamaguchi Hironori ; Chao YAN ; Zhongyin YANG ; Kai YIN ; Yonemura Yutaka ; Wei-Peng Yong ; Jiren YU ; Jun ZHANG ; Asian Gastric Cancer NIPS Treatment Collaborative Group ; Shanghai Anticancer Association, Committee of Peritoneal Tumor
Journal of Surgery Concepts & Practice 2025;30(4):277-294
Gastric cancer with peritoneal metastasis (GCPM) is a common and lethal manifestation of advanced gastric cancer, with a median survival of only 5-11 months. This consensus was developed by 30 experts from Asia (China, Japan, Korea, and Singapore) using the Delphi method and the GRADE evidence grading system. A total of 29 statements were formulated, covering the diagnosis and assessment of GCPM, indications for laparoscopic exploration and NIPS (normothermic intraperitoneal and systemic treatment), treatment regimens, prevention and management of complications, criteria for conversion surgery, and postoperative intraperitoneal therapy. The consensus aims to standardize clinical practice and improve the prognosis of patients with GCPM.
9.Clinical value of low molecular weight heparin bridging therapy for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents
Wei YANG ; Jinlin LIU ; Kai LIN ; Yong PAN ; Fan LUO ; Gaopin ZHAO ; Chun YANG
Chinese Journal of Digestive Surgery 2025;24(9):1180-1185
Objective:To investigate the clinical value of low molecular weight heparin bridging therapy for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents.Methods:The propensity score matching and retrospective cohort study was conducted. The clinical data of 126 patients undergoing tension-free inguinal hernia repair who with long-term oral antiplatelet agents and admitted to Sichuan Academy of Medical Sciences & Sichuan Provincial People′s Hospital (Affiliated Hospital of University of Electronic Science and Technology of China) from January 2017 to January 2025 were collected. There were 120 males and 6 females, aged (74±9)years. Of the 126 patients, 77 patients who discontinued antiplatelet agents alone before inguinal hernia repair were set as the drug withdrawal group, and 49 patients who discontinued antiplatelet agents with low molecular weight heparin bridging therapy before inguinal hernia repair were set as the bridging group. Observation indicators: (1) propensity score matching and comparison of general data of patients between the two groups after matching; (2) intraoperative and postopera-tive conditions; (3) follow-up. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test or Fisher exact probability. Propensity score matching was performed using the 1∶1 nearest neighbor matching method. The caliper value was set as 0.1. Results:(1) Propensity score matching and comparison of general data of patients between the two groups after matching. Of the 126 patients, 90 patients were success-fully matched, with 45 cases in each of the drug withdrawal group and the bridging group. After propensity score matching, the elimination of hernia ring size, activated partial thromboplasmin time and surgical method factors confounding bias ensured comparability. (2) Intraoperative and postoperative conditions. After propensity score matching, patients using plasma drainage tubes during the operation in the drug withdrawal group and the bridging group were 8 and 1, respec-tively, showing a significant difference between the two groups ( P<0.05). The visual analogue scale scores of patients in the drug withdrawal group and the bridging group at 48 hours after surgery were 2(range, 1-2) and 2(range, 2-3), respectively, showing a significant difference between the two groups ( Z=-2.57, P<0.05). (3) Follow-up. After propensity score matching, all 90 patients were followed up after surgery for 16.5(range, 9.0-30.0)days. During the follow-up period, there was no significant difference in pain, seroma, incisional infection, readmission within 30 days after surgery getween two groups (P>0.05). No serious thrombotic events occurred in either group of patients, and no patient died. Conclusion:Compared with patients who discontinued antiplatelet agents alone before surgery, preoperative low molecular weight heparin bridging therapy after discontinua-tion of medication is safe and feasible for patients undergoing inguinal hernia repair who with long-term oral antiplatelet agents, in additon to less plasma drainage tubes using during the operation and without more risk of bleeding, but more postoperative pain.
10.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

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